Cleared Special

K003823 - SCS DT-02 TRANSVERSE CONNECTOR

K003823 is an FDA 510(k) clearance for SCS DT-02 TRANSVERSE CONNECTOR, manufactured by Ortho Tec, LLC. The device is a Class 2 Orthopedic device with product code KWP cleared through the Special 510(k) pathway after a 212-day FDA review.

K003823 · Ortho Tec, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
212d
Days
Class 2
Risk

K003823 is an FDA 510(k) clearance for the SCS DT-02 TRANSVERSE CONNECTOR. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Ortho Tec, LLC (Beverly Hills, US). The FDA issued a Cleared decision on July 11, 2001 after a review of 212 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K003823

510(k) Number K003823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2000
Decision Date July 11, 2001
Days to Decision 212 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 122d · This submission: 212d
Pathway characteristics
Modification to existing cleared device.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - KWP Appliance, Fixation, Spinal Interlaminal

All 415
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K003823.
TRI-FIX SPINAL FIXATION SYSTEM
K011830 · Endius, Inc. · Jul 2001
SYNTHES CERVIFIX SYSTEM
K011969 · Synthes (Usa) · Jul 2001
SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
K010681 · Depuyacromed · Jul 2001
CD HORIZON SPINAL SYSTEM, 4.5 ROD FOR POSTERIOR APPLICATION
K010181 · Medtronic Sofamor Danek, Inc. · Jun 2001
CD HORIZON SPINAL SYSTEM
K011508 · Medtronic Sofamor Danek, Inc. · Jun 2001
BUTTERFLY PLATE FUNCTION SYSTEM
K010632 · Medtronic Sofamor Danek USA, Inc. · May 2001
K003823 · SCS DT-02 TRANSVERSE CONNECTOR
Download PDF FDA Summary Ortho Tec, LLC